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Pharmaceuticals / Submissions and Approvals

Celltrion and Teva’s Rituximab Biosimilar Gains FDA Approval

Dec. 7, 2018
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The FDA announced the first biosimilar of Roche’s blockbuster cancer drug Rituxan (rituximab) — approving Teva and Celltrion’s Truxima (rituximab-abbs) for treating non-Hodgkin’s lymphoma.

The 15th biosimilar to be cleared by the FDA, Truxima is approved for treating adult patients with:

  • Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent;
  • Previously untreated follicular, CD20-positive, B-cell NHL in combination with first- line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as a single-agent maintenance therapy; and
  • Non-progressing (including stable disease), low-grade, CD20­ positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine and prednisone (CVP) chemotherapy.

“We’re seeing more biosimilar drugs gain market share as this industry matures,” Commissioner Scott Gottlieb said in announcing the approval.

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